摘要
试验用药物管理是药物临床试验管理的重要环节,合理、安全、有效地管理试验用药物是保证临床试验结果真实可靠和受试者安全的有效措施。试验用药物由申办者提供,使用和管理由研究者负责。试验用药物的管理是一个环形管理过程,任何一个环节管理不规范,都可能影响药物临床试验的质量。本文系统阐述了制度的建设,合格的药物管理人员,药物的接收、保管、发放、回收和返还等药物管理的关键环节,为药物临床试验机构对试验药物的管理提供参考。
Drug management is an important part in management of drug clinical trials. Drug management should be safe, reasonable and effective, which can ensure the reliablity of the clinical trial results and the safety of subjects. The drug for clinical trials was provided by the sponsor, and managed by investigator. Drug management is an annular management process. The management of drug can affect the quality of drug clinical trial. The system construction, qualified drug management personnel, reception, storage, dispensing, recycle and rejection in drug management were discussed in this paper, so as to provide reference for drug management in drug clinical trial institution.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2014年第7期489-491,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
临床试验
药物
组织和管理
clinical trials
drug
organization and administration
